|GenVec up on new agreement. Alphatec lowers outlook. FDA says no to Dusa Pharma|
|By BioMedReports.com Staff|
|Friday, 06 August 2010 18:15|
Below is a list of the companies that made news in the healthcare sector on Friday, August 6, 2010.
GenVec, Inc. (Nasdaq:GNVC) today announced a new agreement for the supply of services relating to development materials with Novartis, related to the companies' collaboration in hearing loss and balance disorders. Under this new agreement, GenVec could receive approximately $13 million over four years to manufacture clinical trial material for up to two lead candidates.
"This contract supports our ongoing collaborative efforts with Novartis to uncover solutions to the unfortunate and widespread problems of hearing loss and balance disorders," said Dr. Paul Fischer, GenVec's President and Chief Executive Officer. "This new agreement with Novartis will enable the manufacture of a potential product candidate to address this important unmet medical need." Preclinical results suggest that delivery of the atonal gene using GenVec's innovative adenovector technology may have the potential to restore hearing and balance function.
Shares of GenVec jumped nearly 12% in Friday trading, moving up 6 cents to $0.57.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced Thursday after the bell financial results for the fiscal quarter ended June 30, 2010.
The company reported results that were below estimates and also lowered its revenue forecast. Alphatec cited, primarily due to pricing pressure, slower spinal device sales in the U.S. as well as in Europe.
Shares of Alphatec were nearly cut in half, dropping $2.03 or 45.93% to close Friday's trading at $2.39.
DUSA Pharmaceuticals, Inc. (Nasdaq:DUSA) reported today that on the afternoon of August 5, 2010 the U.S. Food and Drug Administration notified DUSA that it has not granted Orphan Drug Designation for the use of Levulan (aminolevulinic acid HCl) Photodynamic Therapy (PDT) for the prevention of cutaneous squamous cell carcinomas (SCCs) in patients who have a proven history of multiple localized cutaneous SCCs over a 12 month period. The FDA acknowledged that cutaneous SCC is a serious problem in patients at high risk for developing SCCs, such as solid organ transplant recipients (SOTRs), and that aminolevulinic acid would be a potential preventative therapy in these patients. However, the FDA also stated that they believe there are other factors which place patients at high risk of developing SCCs that should be included in determining the target population. To be eligible for Orphan Drug Designation, the drug must target a disease that affects fewer than 200,000 patients in the United States.
"We believe that we appropriately identified the target population and are disappointed that the FDA has declined to grant Levulan PDT Orphan Designation for this indication. DUSA feels that prevention of SCCs in this patient population would represent a significant advance in the management of these high risk patients," said Robert Doman, DUSA's President and Chief Executive Officer. "Without the regulatory protection and development opportunities that Orphan Drug Designation affords our resources are better utilized in other areas; therefore, we plan to close out our SOTR pilot clinical trial program over the next few months."
Shares of DUSA fell more than 9%, dropping 23 cents to $2.29.
Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) announced today that it has agreed to sell a total of 8,955,224 shares of its common stock, at a price of $6.70 per share, in a registered direct public offering to entities affiliated with Deerfield Management, a healthcare investment organization. Arena expects to receive gross proceeds, before expenses, of approximately $60 million.
In a seperate release, Arena, along with Eisai Inc. announced today that the US Food and Drug Administration has notified the company of the confirmed scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 16, 2010, for the review of the lorcaserin New Drug Application (NDA). Lorcaserin, which Arena discovered and has developed for weight management, is intended for obese patients as well as overweight patients who have at least one weight-related co-morbid condition.
"Our primary objective at this time is to obtain FDA approval of lorcaserin," said Jack Lief, Arena's President and Chief Executive Officer. "We have been preparing for this anticipated Advisory Committee meeting, and look forward to reviewing lorcaserin's profile with the panel members."
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced that it has entered into definitive agreements to sell 1,351,352 shares of its common stock at a price per share of $1.11 pursuant to a registered direct offering to two large mutual funds, representing gross proceeds of $1.5 million.
The closing of the offering is expected to take place on August 9, 2010, subject to the satisfaction of customary closing conditions. Catalyst intends to use the proceeds from the offering for general corporate purposes.
The shares are being offered by Catalyst Pharmaceutical Partners, Inc. pursuant to a shelf registration statement filed with the Securities and Exchange Commission that was declared effective on June 26, 2008.
Patrick J. McEnany, Catalyst's Chief Executive Officer, said, "We expect that this financing will provide sufficient capital for Catalyst to operate into early 2012 and through the announcement of top-line results of our CPP-109 U.S. Phase II(b) cocaine trial."
Shares of Catalyst finished the day up 9 cents to $1.20, more than 8% higher than yesterdays close of $1.11.
Cypress Bioscience, Inc. (NASDAQ:CYPB), a pharmaceutical company engaged in the development of innovative drugs to treat central nervous system disorders, today announced that its Board of Directors has unanimously concluded that the unsolicited, non-binding proposal by Ramius LLC to acquire all of the outstanding shares of Cypress common stock not owned by Ramius for $4.00 per share in cash grossly undervalues Cypress' current business and future prospects and consequently is not in the best interests of Cypress' other stockholders.
Lannett Company, Inc. (AMEX: LCI), a manufacturer of generic pharmaceuticals, announced today that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application (ANDA) for Ondansetron Injection, USP, 2 mg/mL, Single-Dose Vials. Ondansetron Injection, USP, 2 mg/mL is the generic version of GlaxoSmithKline’s Zofran Injection, 2 mg/mL. For the 12 months ending December 2009, Ondansetron Injection, USP, 2 mg/mL had U.S. sales of approximately $58 million at Average Wholesale Price. A launch date for the product has not been set.
"Ondansetron Injection is another product coming out of our joint venture with Wintac Ltd. and the second injectable product for which we filed an ANDA and received FDA approval," said Arthur Bedrosian, president and chief executive officer of Lannett. "The additional dosage form broadens our product offering and builds our presence in the injectable market."
Ondansetron Injection, USP, 2 mg/mL is indicated for the prevention of postoperative nausea and vomiting and for the prevention of chemotherapy-induced nausea and vomiting.
The Medicines Company (NASDAQ:MDCO) today announced that the U.S. Patent and Trademark Office (PTO) has granted a one-year interim extension of the term of U.S. Patent No. 5,196,404, the principal U.S. patent that covers Angiomax, until August 13, 2011.
The PTO routinely grants such interim extensions when required to provide time to process innovators' applications for patent term extension under the Hatch Waxman Act.
The Company expects the new patent expiry date to be listed in the FDA "Orange Book."
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex:ANX) today reported financial results for the three and six months ended June 30, 2010.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.